Efficacy of the ASPEN Intervention Program in Low-Resource Communities (ASPEN)

Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities

The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN)

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra B Vanegas, PhD; Phone Number: 5122454579; Email: svanegas@txstate.edu
• Study Contact Backup: Name: Sandy Magaña, PhD, MSW; Phone Number: 5122329216; Email: smagana@austin.utexas.edu

Study Locations

• United States
  • Texas
    • San Marcos, Texas, United States, 78666
      • Recruiting
      • Texas State University
      • Contact: Sandra B Vanegas, PhD; Phone Number: 512-245-4579; Email: svanegas@txstate.edu
      • Principal Investigator: Sandra B Vanegas, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Child is between 18 months through 6 years of age
• Child has a medical diagnosis or educational classification of Autism or Autism Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F) and/or Social Communication Questionnaire (SCQ)
• Child resides in a low-resource household as determined by at least one of the following criteria:
• -Child or family has Medicaid as an insurance provider
• -Child's primary caregiver has achieved a high school or lower education
• -Child resides in a household with an annual income of 200% of the Federal Poverty Level

Exclusion Criteria:

• Primary caregiver does not speak/understand English or Spanish
• Child is younger 18 months or older than 6 years of age
• Child does not have a medical diagnosis or educational classification of Autism/ASD or does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ
• Child does not reside in low-resource household

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.	Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN); The ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior.; Other Names: ASPEN
NO_INTERVENTION: Control Group; The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive Behavior	Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome	Baseline to Post-Intervention (12-14 weeks post baseline) Change
Adaptive Behavior	Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome	Baseline to Follow-Up (24-28 weeks post baseline) Change
Parenting Stress	Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome	Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parenting Stress	Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome	Baseline to Follow-Up (24-28 weeks post baseline) Change
Parent Empowerment	Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parent Empowerment	Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome	Baseline to Follow-Up (24-28 weeks post baseline) Change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Challenging Behavior	Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome	Baseline to Post-Intervention (12-14 weeks post baseline) Change
Child Challenging Behavior	Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome	Baseline to Follow-Up (24-28 weeks post baseline) Change
Family Quality of Life	PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome	Baseline to Post-Intervention (12-14 weeks post baseline) Change
Family Quality of Life	PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome	Baseline to Follow-Up (24-28 weeks post baseline) Change

Collaborators and Investigators

• Sponsor: Texas State University, San Marcos
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Sandra B Vanegas, PhD, Texas State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2020
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Autism; Parent-mediated intervention; Naturalistic developmental behavioral intervention; Low resource households
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 90IFST0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available 1 year after study completion.
• IPD Sharing Access Criteria: Electronic data from assessments will be submitted to Inter-university Consortium for Political and Social Research within 1 year after study completion for archival and storage purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No